MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC ASCENT - BALLOON CATHETER; CES BALLOON CATHETER

Catalog Number BRS00040700

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2011

Event Type  malfunction  

Event Description

It was reported that there was inflation/deflation difficulty with the ascent balloon, and product analysis revealed a longitudinal tear in the balloon.The device had been prepped prior to the start of the case with a 1cc syringe using a single-prep technique.It was reported that the balloon did not inflate/deflate properly during prep, and the balloon was not used in the patient.Another balloon was used, and all went well.A mixture of 50/50 contrast was used.No complications resulted.

Manufacturer Narrative

(b)(6).Complaint conclusion: the device was returned for analysis.No defects were found during the catheter outer surface inspection, except in the balloon area where a longitudinal tear of 12mm from the proximal seal and the distal seal was found.The catheter flushed appropriately.The balloon was ruptured, so the balloon could not be inflated, and inflation/deflation verification was not possible.The length between the proximal seal and the distal seal was 12.0mm.This is an indication that the balloon was over inflated, which resulted in stretching the balloon and possibly led to rupture.A review of the manufacturing documentation revealed no issues that could be related to the complaint.The length between the proximal seal and the distal seal was 12.0mm, which means that the balloon was overstretched, and as a result, the unit was damaged.Prior investigations revealed that one of the possible failures when the balloon is over inflated is excessive pressure on the balloon which may lead to longitudinal tears.Therefore, the root cause appears to be balloon over inflation.There is 100% leak testing performed on each balloon catheter before it is released to determine whether the vent hole is open and whether or not the balloon leaks, so it is not likely that the balloon left the manufacturing facility with a leak or a rupture.Since there were no manufacturing issues found during the analysis, no corrective actions were taken.This mdr is being submitted as part of a retrospective review as the result of a recent fda audit and with accordance to the requirements of code of federal regulations - 21 cfr part 803, medical device reporting.

• Brand Name: ASCENT - BALLOON CATHETER
• Type of Device: CES BALLOON CATHETER
• Manufacturer (Section D): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4060576
• MDR Text Key: 17296775
• Report Number: 1226348-2014-00356
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/01/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2011
• Device Catalogue Number: BRS00040700
• Device Lot Number: F38851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2010
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2011
• Initial Date FDA Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1